IMVEXXY Dosage & Rx Info | Uses, Side Effects

Imvexxy Generic Name & Formulations

Legal Class

General Description

Estradiol 4mcg, 10mcg; vaginal inserts.

Pharmacological Class

Estrogen.

How Supplied

Vaginal inserts—8, 18

Storage

Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).

Manufacturer

TherapeuticsMD, Inc.

Generic Availability

Mechanism of Action

Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH), follicle stimulating hormone (FSH), through a negative feedback mechanism. Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.

Imvexxy Indications

Indications

Moderate to severe dyspareunia due to menopause.

Imvexxy Dosage and Administration

Adult

Use lowest effective dose for the shortest duration. Initially one 4mcg insert intravaginally once daily for 2 weeks, then 1 insert twice weekly every 3–4 days. Reevaluate periodically.

Children

Not applicable.

Imvexxy Contraindications

Contraindications

Undiagnosed abnormal genital bleeding. Breast cancer or history of. Estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease (eg, stroke, MI) or a history of. Hepatic impairment or disease. Protein C, protein S, or antithrombin deficiency or other thrombophilic disorders.

Imvexxy Boxed Warnings

Boxed Warning

Endometrial cancer. Cardiovascular disorders. Breast cancer. Probable dementia.

Imvexxy Warnings/Precautions

Warnings/Precautions

Increased risk of endometrial carcinoma or hyperplasia in women with intact uterus (adding progestin is essential). Not for prevention of cardiovascular disease or dementia. Increased risk of cardiovascular disorders (eg, stroke, MI, VTE); discontinue if occurs or suspected. Manage risk factors for cardiovascular disease and venous thromboembolism appropriately. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Increased risk of breast or ovarian cancer. Risk of probable dementia in women ≥65yrs of age. Gallbladder disease. Severe hypercalcemia in breast cancer or bone metastases. Visual abnormalities. Permanently discontinue if papilledema or retinal vascular lesions reveals on exam. Preexisting hypertriglyceridemia. History of cholestatic jaundice. Discontinue if pancreatitis, hypercalcemia, or recurrence of cholestatic jaundice occurs. Monitor thyroid function. Monitor conditions that may predispose to fluid retention (eg, cardiac or renal impairment); discontinue if medically concerning fluid retention occurs. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Asthma. Diabetes. Epilepsy. Migraine. Porphyria. SLE. Hepatic hemangiomas. Do initial complete physical and repeat annually (include Pap smear, mammogram, BP). Reevaluate periodically. Pregnancy: not indicated. Nursing mothers: not recommended.

Imvexxy Pharmacokinetics

Distribution

Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in blood largely bound to SHBG and albumin.

Metabolism

Hepatic.

Elimination

Renal.

Imvexxy Interactions

Interactions

May be antagonized by CYP3A4 inducers (eg, St. John's wort, phenobarbital, carbamazepine, rifampin). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice). Concomitant thyroid replacement; may need to increase thyroid dose. May interfere with lab tests (eg, thyroid, PT, coagulation factors, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding or plasma proteins).

Imvexxy Adverse Reactions

Adverse Reactions

Headache; thromboembolism, neoplasms.

Imvexxy Clinical Trials

See Literature

Imvexxy Note

Not Applicable

Imvexxy Patient Counseling